Fluconazole

Fungal infections, both superficial and systemic, are a significant public health concern worldwide. Immunocompromised patients, including those undergoing chemotherapy, organ transplant recipients, and individuals with HIV/AIDS, are especially susceptible. Among the most widely prescribed antifungal medications is Fluconazole, a triazole antifungal agent with broad-spectrum activity and excellent safety and efficacy profiles.

At BluepillExpress, we offer world-class third-party manufacturing of Fluconazole in multiple formulations. Our WHO-GMP certified manufacturing units, adherence to international quality standards, and client-centric manufacturing model allow us to serve pharmaceutical companies, health ministries, NGOs, and institutional buyers globally.

About BluepillExpress

BluepillExpress is a leading Indian pharmaceutical company that provides third-party and contract manufacturing services for generic and branded drugs. With a strong presence in 30+ countries across Asia, Africa, CIS, the Middle East, and Latin America, we cater to:

• Public health procurement agencies
• International donor organizations
• Private-label pharmaceutical brands
• Hospital supply chains
• Importers and distributors

We are WHO-GMP and ISO 9001:2015 certified and have in-depth expertise in manufacturing antifungals, antivirals, antibiotics, analgesics, and other therapeutic categories.

Product Overview: Fluconazole

Fluconazole is a synthetic triazole antifungal agent used to treat and prevent a variety of fungal infections, particularly those caused by Candida and Cryptococcus species. Its excellent oral bioavailability, once-daily dosing, and ability to penetrate the central nervous system make it a preferred agent in both prophylactic and therapeutic antifungal strategies.

Pharmacological Class: Triazole antifungal
Mechanism of Action: Inhibits fungal cytochrome P450 enzyme 14α-demethylase, interfering with ergosterol synthesis and inhibiting fungal cell membrane formation

Therapeutic Uses of Fluconazole

Fluconazole is indicated for:

• Oropharyngeal and esophageal candidiasis
• Vaginal candidiasis
• Systemic Candida infections (candidemia, disseminated candidiasis)
• Cryptococcal meningitis
• Fungal prophylaxis in immunocompromised patients (e.g., HIV/AIDS, cancer chemotherapy, organ transplant)
• Dermatomycoses and tinea infections (off-label)

Its utility across multiple organ systems and infection types makes Fluconazole a vital antifungal for both acute and long-term treatment.

Available Formulations and Dosage Strengths

BluepillExpress manufactures Fluconazole in various forms and strengths tailored to both outpatient and inpatient use:

• Fluconazole 150 mg Tablets – Single-dose therapy for vaginal candidiasis
• Fluconazole 50 mg, 100 mg, 200 mg Tablets/Capsules – For extended treatment
• Fluconazole 200 mg/100 ml Intravenous Infusion – For systemic infections and hospitalized patients
• Fluconazole 50 mg/5 ml Oral Suspension – Pediatric and elderly use
• Custom formulations (e.g., dispersible tablets, sachets) available upon request

All formulations conform to global pharmacopoeial standards (IP/BP/USP).

Key Benefits of Fluconazole

• High oral bioavailability (>90%) and extensive tissue penetration
• Once-daily dosing improves patient compliance
• Safe in immunocompromised individuals
• Effective against CNS fungal infections like cryptococcal meningitis
• Can be used prophylactically or therapeutically
• Generally well tolerated with minimal adverse reactions
• Available in oral, suspension, and injectable forms
• Included in the WHO Model List of Essential Medicines

Manufacturing Infrastructure at BluepillExpress

BluepillExpress maintains state-of-the-art manufacturing facilities for antifungals like Fluconazole, ensuring safety, potency, and consistency across every batch.

Core Infrastructure Features:

• Advanced tablet compression and encapsulation units
• Liquid filling lines for oral suspensions and IV infusions
• HEPA-filtered cleanrooms for sterile injectable manufacturing
• Dedicated zones for antifungal production to avoid cross-contamination
• Humidity and temperature-controlled storage facilities
• High-capacity batch production with scalability for large institutional orders

Our integrated production model ensures efficient manufacturing of small, medium, and large orders with a fast turnaround time.

Quality Assurance and Quality Control

At BluepillExpress, product integrity is our top priority. Our QA/QC processes are aligned with international norms to guarantee the efficacy, safety, and compliance of every Fluconazole product.

Quality Protocols Include:

• Testing of raw materials and active pharmaceutical ingredients
• In-process quality control (IPQC) checks during manufacturing
• Final product testing: assay, dissolution, pH, sterility (for injectables), and microbial limits
• Stability testing under ICH conditions (Zone II and Zone IVb)
• Batch release based on approved specifications and validation
• Documentation: Certificate of Analysis (CoA), Batch Manufacturing Records (BMR), and MSDS

We implement full traceability from sourcing to delivery to ensure global regulatory compliance.

Shelf Life and Storage Conditions

• Shelf Life: Typically 24–36 months depending on dosage form and packaging
• Storage Conditions: Store below 30°C in a dry place; protect from light and moisture
• Packaging Materials: Moisture-resistant blister packs and tamper-proof HDPE bottles or ampoules for injectables

All products are packaged to withstand diverse climatic conditions, including tropical and semi-tropical zones.

Packaging and Private Labeling Services

BluepillExpress offers custom packaging and private-label solutions that align with market preferences and regulatory requirements.

Packaging Options:

• Tablets/Capsules: 1×1, 1×3, 10×1, 10×10 blister packs
• Oral Suspension: PET or amber glass bottles (60 ml/100 ml) with dosing cup
• Injectables: IV infusion bottles or bags, labeled and serialized
• Outer cartons: Multilingual and barcoded for regulatory compliance

Private Label Features:

• Custom branding and logo placement
• Country-specific language inserts and artwork
• Serialization, barcoding, and tamper-proof labeling
• Flexible MOQs for startups and pilot projects

We support marketing teams with artwork design and regulatory copywriting assistance.

Regulatory Documentation and Global Compliance

BluepillExpress ensures smooth product registration and regulatory approval through comprehensive documentation and technical support.

Documents Provided:

• WHO-GMP certificate
• Certificate of Pharmaceutical Product (COPP)
• Free Sale Certificate (FSC)
• Certificate of Analysis (CoA)
• Product Dossier (CTD/ACTD format – Modules 1 to 5)
• Master Formula Records and validation reports
• Material Safety Data Sheet (MSDS)
• Stability and impurity profile reports

We have a proven track record of regulatory approvals across Africa, Southeast Asia, CIS, and Latin America.

Logistics and Export Management

With years of experience in pharmaceutical exports, BluepillExpress handles all aspects of logistics and shipping with accuracy and transparency.

Logistics Features:

• Worldwide shipping via sea, air, or courier
• Temperature-controlled and insulated packaging on request
• Door-to-port or door-to-door delivery options
• Regulatory-compliant export documentation
• Coordination with pre-shipment inspection agencies (SGS, Intertek, Bureau Veritas)

Our logistics team ensures on-time delivery of Fluconazole consignments, even in challenging geographies.

Target Markets and Applications

BluepillExpress offers Fluconazole manufacturing services to:

• Pharmaceutical importers and wholesalers
• Hospitals and private medical chains
• Government healthcare tenders and NGO supply chains
• Retail pharmacy networks and e-pharmacies
• Startup brands and OTC segment leaders

Our scalable and flexible production is ideal for both high-volume supply contracts and small private-label projects.

Why Choose BluepillExpress for Fluconazole Manufacturing?

• WHO-GMP certified infrastructure and robust quality control
• Extensive export experience and global documentation support
• Full product range: tablets, capsules, suspension, and injectables
• Customizable branding and packaging for all market needs
• Fast production turnaround with strict batch validation
• Expertise in regulatory filing and dossier preparation
• Transparent, ethical, and long-term partnership approach

Whether you’re entering a new market or expanding an existing portfolio, BluepillExpress offers a complete third-party manufacturing solution tailored to your needs.

Conclusion

Fluconazole is a critical antifungal agent used across the spectrum of fungal infections and remains a cornerstone in antifungal therapy worldwide. With rising demand, particularly in immunocompromised populations, the availability of a trusted manufacturing partner is vital for global health stakeholders.

BluepillExpress brings together technical expertise, regulatory strength, global compliance, and reliable manufacturing capabilities to deliver high-quality Fluconazole products for domestic and international markets. Our commitment to quality, affordability, and service excellence positions us as the partner of choice for third-party manufacturing of antifungal medications.